The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Refinity Rotational Ivus Catheter, Refinity Rotational Ivus Catheter, Short Tip.
| Device ID | K160583 |
| 510k Number | K160583 |
| Device Name: | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VOLCANO CORPORATION 3721 VALLEY CENTRE DRIVE SUITE 500 San Diego, CA 92130 |
| Contact | Brian Park |
| Correspondent | Brian Park VOLCANO CORPORATION 3721 VALLEY CENTRE DRIVE SUITE 500 San Diego, CA 92130 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-01 |
| Decision Date | 2016-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225002831 | K160583 | 000 |
| 00845225002824 | K160583 | 000 |